FDA Lays Out Final Rules for Pediatric Labeling

April 3, 2019

The FDA released a final guidance on pediatric labeling of prescription drugs that, among other recommendations, calls for black box warnings on medicines with inactive ingredients that might be dangerous to babies and children.

The guidance lays out four scenarios that the agency says will dictate how a drug’s label should be written to ensure that information for pediatric populations is consistently placed, “whether positive, negative, or inconclusive.”

When a drug can be used safely in pediatric populations, it should be made clear in the drug’s “indications and usage” section. The “dosage and administration” subsection should carefully describe the pediatric doses as well as “important preparation and administration instructions” and marketers should highlight adverse reactions that are novel or unique in pediatric patients, the agency says.

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